Project management

     Pharmaceutical Benefits Advisory Committee (PBAC)

     Medical Services Advisory Committee (MSAC)

     Co-Dependent Technologies

     Prostheses List Advisory Committee (PLAC)

     PHARMAC

Reimbursement Submissions

Development of a reimbursement submission for the Pharmaceutical Benefits Advisory Committee (PBAC), Medical Services Advisory Committee (MSAC) or both in the case of a co-dependent technology, and the prerequisite application for consideration by the PICO Advisory Sub-committee (PASC) is a crucial step in any market access strategy.

Planning and project management of the submission process is important to ensure that the rate-limiting steps, such as obtaining real-world clinical  evidence, are incorporated.

Review cycles should be scheduled early to avoid the need for rework, especially changes in economic model variables which subsequently impact the outputs, budget impact models and the write-ups of both.

Adequate time to contemplate the implications and interpretations of models is essential.

A submission that receives a positive recommendation for subsidy will, however only provide a seat at the negotiating table. What happens at the table depends on the effectiveness of the overall market access strategy.

New Zealand (NZ) PHARMAC submissions should not be considered as ‘mini-me’ versions of an Australian submission. Although the NZ system is less prescriptive with regards to Guidelines and data presentation (with peer-reviewed publications most important), the focus is on the impact of a new product at the patient level and, in particular for the different ethnic groups that constitute NZ society.

TACS Healthcare co-dependent technology

Case Study

Co-Dependent Technology

Situation:

A PBS-listed lung cancer medicine required a positive mutation test as one criterion for subsidised patient access.  Unfortunately, the test was not listed on the MBS, although a positive MSAC recommendation had been received for a later line of treatment.

Involvement:

Two years of intensive collaboration involving the marketing company including global payer, statistics and diagnostics colleagues, other marketing companies, and local stakeholders; strategy development, data generation and project management of one major co-dependent submission, and subsequent major & minor PBAC and MSAC resubmissions; liaison with the DoH regarding the pilot reimbursement process, and conduct of risk share and deed negotiations with the Commonwealth Government.

Outcome:

Simultaneous reimbursement listing of the mutation test on the MBS and medicine on the PBS for first line use achieved.

Poster presentation at ISPOR Annual International Meeting, Philadelphia May 2015.

Case Study

Economic Model Development

Situation:

The global economic model for a first-in-class medicine was predicting a low probability of cost-effectiveness based on Phase 2 single arm data.

Involvement:

As the Australian market access project lead, in collaboration with a highly skilled local HTA consultant, drove access to individual patient data and the conduct of additional payer analyses in the face of significant pushback from the global product and statistics teams. The Australian model developed using these inputs and a different method had a significantly reduced ‘arc of uncertainty’.

Outcome:

During this process, a subgroup with improved overall survival was identified. Additionally, subsequent data read-outs demonstrated the robustness of the Australian economic model, which predicted and fitted the RCT data perfectly, while the initial global model became unstable. The Australian model has since been adopted by HTA markets globally in reimbursement applications.

TACS Healthcare Economic Model Development